NEW ENGLAND DRUG METABOLISM DISCUSSION GROUP

NEWS + EVENTS

Our NEDMDG Winter Meeting will be held as a webinar on December 7, 2020 at 7:00 PM EST.

REGISTRATION REQUIRED FOR EVENT LINK

TOPIC

“How DMPK Embraces its Role in Supporting Gene Therapy”

Gene therapy technology holds an enormous promise for patients in treating a variety of diseases. The rising numbers of clinical trials undeniably speak to this ever-expanding field.  Since the approval of Luxturna and Zolgensma, recombinant adeno-associated virus (rAAV)-as delivery vehicle further confirms its utility and continues to be the leading platform for gene therapy. While the multi-disciplinary functions within each company become more knowledgeable about rAAV-based gene delivery, the roles and responsibilities for each function also becomes more defined. DMPK plays a substantial role in advancing therapeutic gene therapy modality from preclinical research to clinical development, in particular  characterization of drug product biodistribution, immunogenicity assessment, and multiple platform bioanalytical assays and biomarker analysis, as well as first in human dose projection. The overview of each role, strategic approach to existing challenges and potential mitigation plans will be discussed.

 

By Dr. Nancy Chen from Takeda

This meeting is sponsored by

PAST EVENTS

 NEDMDG First Webinar

Our NEDMDG Spring Meeting will be held as a webinar on Wednesday September 23, 2020 at 10:00 am. 

REGISTRATION REQUIRED FOR EVENT LINK

TOPIC

“Drug metabolism by human gut microbes.”

Oral medicinal drugs can exhibit incomplete absorption in the upper gastrointestinal tract or reach the gut after enterohepatic circulation. In these circumstances, drugs encounter enormous densities of commensal microbes. These microbes collectively encode 150-fold more genes than the human genome, including a rich repository of enzymes with the potential to metabolize drugs. However, the contribution of the microbiome to drug and drug metabolite exposure in the GI tract and in circulation is largely unexplored.

I will describe examples that suggest that gut microbial activity can be responsible for a significant portion of systemic exposure to a toxic drug metabolite, even if the drug exhibits high bioavailability, if the same metabolite is readily produced by hepatic extracts in vitro, and if drug metabolite levels are low in feces. I will also introduce our efforts to explore the spectrum of microbiome-encoded drug metabolizing activities and to identify microbial genes that predict the capacity of an individual’s gut microbiome to metabolize a drug.

By Dr. Andrew Goodman from Yale University School of Medicine

Andrew L. Goodman, PhD, is the C. N. H. Long Professor of Microbial Pathogenesis at Yale University School of Medicine and Director of the Yale Microbial Sciences Institute. Goodman received his undergraduate degree in Ecology and Evolutionary Biology from Princeton University, his PhD in Microbiology and Molecular Genetics from Harvard University, and completed postdoctoral training at Washington University. His lab uses microbial genetics, gnotobiotics, and mass spectrometry to understand how the gut microbiome contributes to drug metabolism. The Goodman lab works to identify and characterize microbiome-encoded drug metabolizing enzymes, and to define how these microbial activities contribute to drug and drug metabolite exposure in the gut and in circulation. The lab’s contributions have been recognized by the NIH Director New Innovator Award, the Pew Foundation Research Scholars Program, the Dupont Young Professors Award, the Burroughs Wellcome Investigator in Infectious Disease Award, the Howard Hughes Medical Institute Faculty Scholars Program, and the Presidential Early Career Award in Science and Engineering.

This meeting is sponsored by

Our NEDMDG Winter Meeting will be held on Thursday, December 5, 2019 at TAKEDA PHARMACEUTICALS COMPANY, 35 LANSDOWNE STREET, CAMBRIDGE, MA 02139.

TOPIC

“The Drug Metabolism Scientist’s Contribution to the Development of Gene Therapies: It’s not what you do, it’s the way that you do it.”

By Dr. Mark Milton from Novartis

Please check back in a couple of weeks for more information about this event.

This meeting is sponsored by

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